USFDA Current Affairs - 2019
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The US Food and Drug Administration (FDA) has approved use of Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology, world’s first contact lens that automatically darkens when exposed to bright light. It is first of its kind contact lens to incorporate same technology that is used in eyeglasses that automatically darken in the sun.
These contact lens are soft contact lenses indicated for daily use to correct vision of people with non-diseased eyes who are nearsighted (myopic) or farsighted (hyperopic). They can be used by people with certain degrees of astigmatism, an abnormal curvature of the eye.
These contact lenses contain photochromic additive that adapts amount of visible light filtered to eye based on amount of ultra-violet (UV) light to which they are exposed. This additive slightly darkens lenses in bright sunlight that automatically return to regular tint when exposed to normal or dark lighting conditions.
United state Food and Drugs Administration (USFDA) has hiked its fees by 30 percent for new generic drug applications.
Earlier the fee for Abbreviated New Drug Applications (ANDAs) was 58,730 dollars and now has risen by 30 per cent to 76,030 US dollars.
This fee is applicable from 1 October 2015. This move will hit Indian drugmakers as the generic medicines are sold on large scale in Indian market.
Meanwhile USFDA as reduced the fees for facility inspection of foreign companies, this will promote more firms to opt for audit of their facilities by the regulator US FDA.
Further the regulator has also increased the rates of Drug Master File (DMF) by twenty per cent making it 42,170 dollars. All above changed fees is valid till 30 September 2016.
- The hike in fees for new generic drug will put extra burden on small generic drug makers as its costing will increase and eventually will affect the customers in India who primly opt for generics due to its less pricing.
- Fees reduction in facility inspection will encourage Drug Company to opt for auditing from regulator.